Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PCN-101 · 1 trial · 1 indication
Change from baseline to 24 hours after the start of infusion in the Montgomery Asberg Depression Rating Scale (MADRS). The overall score ranges from 0 to 60. Higher scores indicates more severe depression.
| Arm | Type | Description |
|---|---|---|
| PCN-101 30 mg | EXPERIMENTAL | PCN-101 30 mg |
| PCN-101 60 mg | EXPERIMENTAL | PCN-101 60 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| PCN-101 | DRUG | Concentrate for solution for infusion |
| Placebo | DRUG | Concentrate for solution for infusion |
Inclusion Criteria: * Capable of giving and give signed informed consent * Weigh \>= 50 kg and have a body mass index \>= 18 and \<= 35 * Diagnosis of recurrent major depressive disorder (MDD) without psychotic features per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V...
PCN-101 is an investigational small molecule being developed for the treatment of Treatment Resistant Depression (TRD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
PCN-101 is being developed by AtaiBeckley Inc., a biopharmaceutical company publicly traded under the ticker symbol ATAI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Treatment Resistant Depression.
PCN-101 is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 2 clinical trial evaluating PCN-101 in Treatment Resistant Depression has been completed.
PCN-101 has one completed Phase 2 clinical trial, identified as NCT05414422. This randomized, double-blind, placebo-controlled study assessed the safety and efficacy of PCN-101 in 102 patients with Treatment Resistant Depression across the United States, Germany, and Poland.
PCN-101 is a distinct investigational compound developed by AtaiBeckley Inc. No alternative names for PCN-101 have been disclosed in the available clinical trial information.